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FDA is reopening the comment period on a proposed rule, issued jointly with USDA/FSIS in 2005, that proposed to establish general principles that would be the first step in modernizing and updating the framework for food standards (also known as standards of identity). We are reopening the comment period because of the time that has elapsed since the publication of the proposed rule during which time there have been additional technological advances and other changes in the food industry which could help inform the development of a modernized food standards framework.

Statement of Need:

Standards of identity for foods are regulations Congress authorized FDA to issue to promote honesty and fair dealing in the interest of consumers.  FDA’s standards of identity have proved valuable in assuring that food products are consistent across different manufacturers.  They are important for international trade as well as domestic trade and are critical to government expenditures on food for the military, for WIC (women, infants, and children) programs, and in school feeding programs.  However, questions have been raised about whether the regulations concerning standards of identity should be revised in light of changing consumer expectations and subsequent developments in food technology, and global trade.  In 1996, FDA and USDA established a task force to discuss the current and future role of food standards.  The task force determined there were several regulatory options including making no change to the food standards, eliminating all food standards, or using resources to review and revise the food standards to protect consumers without inhibiting technological advances in food preparation and marketing.  FDA and FSIS ultimately decided to propose amending the petition process so the standards of identity would be more internally consistent, flexible for manufacturers, and easier to administer while ensuring product quality and uniformity to consumers, and did so in 2005.

Summary of the Legal Basis:

FDA has established over 280 food standards of identity, in addition to standards of quality and fill of container, under the authority set forth in section 401 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 341).  This section provides in part:

Whenever in the judgment of the Secretary (of Health and Human Services) such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container.

The standards of identity, quality, and fill of container for foods regulated by FDA are codified in title 21, parts 130 to 169 (21 CFR parts 130 to 169).  FDA food standards are established under the common or usual name of a food and often specify the content of the food, generally in terms of the types of ingredients that it must contain (i.e., mandatory ingredients), and that it may contain (i.e., optional ingredients).  FDA food standards may specify minimum and maximum levels of constituents.  They also may describe the manufacturing process when that process has a bearing on the identity of the finished food.  Finally, FDA food standards may also include provisions related to label declaration of ingredients and nomenclature of the food depending on the form, packing medium, and optional ingredients used.

Alternatives:

FDA is proposing to reopen the comment period on the 2005 proposal, to allow for us to update the record and inform decisionmaking on standards of identity.  The only alternative would be to open a docket and request comments and data on the issue generally, which would be a step backward.  FDA does not believe it is in a position to develop a new proposed rule without affording stakeholders and the public a chance to comment and provide new data and information.  After we have reviewed this information, we will be in a position to either publish a new proposed rule or to issue a final rule based on the full record.

Anticipated Costs and Benefits:

There is no cost/benefit analysis associated with reopening a proposed rule to solicit updated comments and information.  The preliminary regulatory impact analysis in the proposed rule evaluated various options and concluded that taking the action covered in the proposed rule will generate net social benefits, and concluded that the social costs of taking the proposed action are likely to be small.  The analysis found that most of the other options were likely to have lower net benefits because they had lower benefits, higher costs, or both.

Risks: